Mazindol treatment for heroin dependence and substance use disorder

Abstract

The present invention relates to mazindol for use in the treatment of dependence and substance use disorder, wherein the substance is an opioid, a composition comprising mazindol and optionally a pharmaceutically acceptable carrier or excipient and/or a diluent, for use in the treatment of substance abuse disorder, wherein the substance is an opioid, and a method of treatment of substance abuse disorder comprising administering mazindol or composition comprising mazindol to a subject, wherein the substance is an opioid. The opioid is preferably heroin.

The invention claimed is: 
     
       1. A method of treatment of substance abuse disorder comprising administering mazindol or composition comprising mazindol to a subject, wherein the substance is an opioid and mazindol is administered daily at a daily dosage range of between 3 mg and 16 mg. 
     
     
       2. The method according to  claim 1 , wherein the substance is heroin. 
     
     
       3. The method according to  claim 1 , wherein mazindol or the composition comprising mazindol is administered via oral administration, preferably in the form of a tablet. 
     
     
       4. The method according to  claim 3 , wherein mazindol or the composition comprising mazindol is administered in the form of a tablet and the tablet comprises 1 to 6 mg of mazindol. 
     
     
       5. The method according to  claim 1 , wherein mazindol is in the form of a multilayer matrix-type tablet comprising:
 at least one immediate-release (IR) layer comprising mazindol and at least one diluent, 
 at least one sustained-release layer (SR) comprising mazindol and at least one sustained-release, pH independent and water-insoluble polymer. 
 
     
     
       6. The method according to  claim 5 , wherein the ratio in weight between the IR layers and the SR layers is between 40:60 and 80:20. 
     
     
       7. The method according to  claim 5 , wherein the tablet has a dissolution of between 60% and 80% at 1 hour, and of between 70% and 90% at 2 hours. 
     
     
       8. The method of  claim 5 , wherein the weight ratio ranges from 50:50 to 70:30. 
     
     
       9. The method of  claim 5 , wherein the weight ratio is 50:50.